NCT03509454 (PROTON) is a clinical trial in Diabetes Mellitus, Type 1, sponsored by Peter Rossing.

Who is sponsoring NCT03509454?

NCT03509454 is sponsored by Peter Rossing.

What condition does NCT03509454 study?

NCT03509454 studies Diabetes Mellitus, Type 1, Diabetes Complications, Diabetic Nephropathies.

Is NCT03509454 still recruiting?

NCT03509454 is currently completed. Last updated 26 April 2018.

Last reviewed 2018-04-26 · How we verify

NCT03509454: PROTON

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PeRsOnalising Treatment Of Diabetic Nephropathy:

Completed Last updated 26 April 2018

What this trial tests

trial in Diabetes Mellitus, Type 1 in 210 participants. Completed in 1 April 2018.

Timeline

1 April 2016

Primary endpoint
1 October 2017

1 April 2018

Quick facts

Lead sponsor	Peter Rossing
Status	Completed
Study type	OBSERVATIONAL
Enrollment	210
Start date	1 April 2016
Primary completion	1 October 2017
Estimated completion	1 April 2018
Sites	1 location across Denmark

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Diabetes Complications — all drugs for Diabetes Complications →
Diabetic Nephropathies — all drugs for Diabetic Nephropathies →

Sponsor

Peter Rossing — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 1 or Diabetes Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. There is an urgent need for discovery of new pathways behind the development and progression of diabetic nephropathy as well as of biomarkers which can identify subjects at risk of developing adverse events. Objective: By using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites and pathways that will point to the putative new mechanisms which underlie the early renal decline. Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Randomized Trial of SGLT2 Inhibitor Identifies Target Proteins in Diabetic Kidney Disease.
Ahluwalia TS, Rönkkö TKE, Eickhoff MK, Curovic VR, et al · · 2024 · cited 7× · PMID 38344728 · DOI 10.1016/j.ekir.2023.11.020

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03509454 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peter Rossing
Last refreshed: 26 April 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03509454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing